Syringe usable as container for storage and preservation of injection fluid

ABSTRACT

A syringe which may be used for storage and preservation of injection fluid includes a hollow cylindrical body which has an outlet end and an inlet end. A rupturable member is provided at the outlet end. A flange is provided at the inlet end. A sealing member, which is desirably a fluid-impermeable membrane, is fixed to the flange to seal the inlet end. A rod is provided on which a piston is connected. The piston is positionable, with respect to the cylindrical body, for entering its interior, rupturing the sealing member and moving toward its outlet end. As a result, the injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod.

United States Patent [1 1 Laj us [451 Sept. 2, 1975 [75] Inventor: Pierre Lajus, Paris, France [73] Assignee: Compagnie Generale de Radiologie,

France 22 Filed: Apr. 22, 1974 21 App1.No.: 462,767

[30] Foreign Application Priority Data Apr. 27, 1973 France 73.15452 [56] References Cited UNITED STATES PATENTS 2,338,102 l/1944 Fields 128/272 3,058,467 10/1962 Faure 128/218 M X 3,684,136 8/1972 Baumann 128/218 M X 3,713,780 1/1973 Shapiro 206/222 X 3,731,853 5/1973 Baumann et a1. 128/272 X 3,754,644 8/1973 Hampel 128/218 R FOREIGN PATENTS OR APPLICATIONS 1,212,565 11/1970 United Kingdom 128/218 P 116,726 6/1918 United Kingdom 128/218 R Primary Exami nerRichard A. Gaudet Assistant Examiner.1. C. McGowan Attorney, Agent, or F irm--Edwin E. Greigg 57 ABSTRACT A syringe which may be used for storage and preservation of injection fluid includes a hollow cylindrical body which has an outlet end and an inlet end. A rupturable member is provided at the outlet end. A flange is provided at the inlet end. A sealing member, which is desirably a fluid-impermeable membrane, is fixed to the flange to seal the inlet end. A rod is provided on which a piston is connected. The piston is positionable, with respect to the cylindrical body, for entering its interior, rupturing the sealing member and moving toward its outlet end. As a result, the injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod.

7 Claims, 5 Drawing Figures PATENTED 35F 975 SHEET 1 BF 2 FIG.4

SYRINGE USABLE AS CONTAINER FOR STORAGE AND PRESERVATION OF INJECTION FLUID BACKGROUND OF THE INVENTION This invention relates to a syringe which may be used as a container for storing and preserving fluids which are to be injected and, more particularly, to such a syringe which may contain its own injection fluid which is thus stored in sterile condition and ready to be used.

In medicine andespecially in radiology, it is often necessary to administer numerous injections of contrast material during prolonged periods of time which requires sterilization operations. These operations require much time and effort.

To reduce the time and effort, at least to a considerable extent, it is known to employ ready to use syringes, i.e., syringes which are sold and stored in a sterile envelope. These syringes, which are generally plastic, are disposed of after use. However, this technique still requires a timeconsuming manipulation to fill the syringe with injection fluid, which has been separately stored and preserved in a separate sealed container.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a syringe which contains its own injection fluid in a sterile manner.

It is another object of the present invention to provide a syringe which advantageously stores and preserves its own injection fluid in a sterile fashion ready for use.

It is an additional object of the present invention to provide a syringe which is at least partially disposable and is of relatively simple construction.

The foregoing objects, as well as others which are to become clear from the text below, are achieved in accordance with the present invention by providing a syringe which may be used for storage and preservation of injection fluid. The syringe includes a hollow cylindrical body which has an outlet end and an inlet end. A rupturable member is provided at the outlet end. A flange or the like is provided at the inlet end. A sealing member, which is desirably a fluid-impermeable mem.

brane, is fixed to the flange or the like to seal the inlet end. A rod is provided on which a piston is connected. The piston is positionable, with respect to the cylindrical body, for entering its interior, rupturing the sealing member and moving toward the outlet end. The move ment of the piston, under the influence of the rod, causes the injection fluid stored and preserved within the hollow cylinder to be removed via the outlet end.

The syringe according to the invention desirably has at its outlet end a rupturable member in the form of a breakable sealed nipple. A first flange, on which there is a fixed, fluid-impermeable membrane, constituting the sealing member, is provided to store and to preserve the injection fluid contained in the syringe in a fluidtight fashion. The membrane is ruptured by the motion of the piston toward the outlet end of the syringe.

In accordance with a preferred embodiment of the invention, the syringe includes a piston which is also made of plastic material, such as polypropylene, which is resistant to the injection fluid. The piston, in this case, also includes a second sealing flange or the like integral with the piston and joined, by fusing or other techniques, to the first flange formed on the body of the syringe. At the place where it is joined to the piston, the second flange has a rupturable region formed by a reduction of its thickness.

In a preferred variant of the preferred embodiment mentioned above, the piston is hollow and its associated piston rod has a tip which conforms to the interior shape of the piston. At a distance equal to the depth of the piston, the tip carries an enlargement of its diameter equal to that of the piston. This enlargement termi nates at a steep angle directed toward the syringe body in order to facilitate the separation of the flange attached thereto.

The invention is to be better understood, and other characteristics and advantages are to become apparent with the aid of the below set forth detailed description and the figures of accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a side view of a syringe according to an illustrative embodiment of the present invention.

FIG. 2 is an exploded, perspective view showing the syringe of FIG. 1, its membrane, piston, and piston rod being shown.

FIG. 3 is an axial, sectional view through a syringe according to a first variant of the embodiment shown in FIGS. 1 and 2.

FIG. 4 is an axial, sectional view through a syringe according to another variant of the embodiment shown in FIGS. 1 and 2.

FIG. 5 is an axial, sectional view of a most preferred embodiment of a syringe according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS' i As visible in FIG. 1, an illustrative embodiment of a syringe according to the present invention includes a hollow, cylindrical body 1, an outlet end of which is equipped with an attachment known per se.

The attachment is defined by a sleeve 2 having interior threads intended to be used to attach the syringe to a needle, a valve, or a catheter, or some other accessory for utilization. At the center of the sleeve 2 is a thin, rupturable member, such as a tube, with a sealed, fluidtight tip (see 20 FIG. 5) intended to be cut off prior to connecting the attachment sleeve 2 to the accessory needle or the like. The tip is intended to be broken easily, for example, by parting, with or without a rupture, along a circumferentially extending line of weakness.

At the other end, which is the inlet end, the hollow, cylindrical body 1 of the syringe has a first flange 3 whose open face is finished to permit sealing with a sealing member 4 (membrane) or a lid by gluing, or fusing, or some other known technique. The purpose of the sealing member 4 is primarily to hold the liquid in the syringe and to prevent its coming in contact with materials which can adulterate it duringstoragei The entire assembly, that is the syringe and sealing member 4 is kept sterile in a fluid-tight enclosure during storage just as in the case of storage of empty syringes. As illustrated in FIG. 2, which is an exploded, pictorial view of the syringe of FIG. 1 showing its lid 4 half removed, the head of a piston 5 which includes a sealing, stiffener flange 6, a point 7 and a seat :8 for a piston rod 9 is further shown.

The head of the piston 5, and possibly its associated rod 9 as well, are kept sterile outside of the syringe in a fluid-tight envelope, which can be the same one that contains the syringe proper.

The use of the syringe, shown in FIGS. I and 2, thus requires tearing off or preparation of the sealing member 4, and putting the piston in its place within the hollow, cylindrical body I.

One of the principal applications of any syringe constructed according to the present invention is for the injection of contrast material during radiographic examinations. In that case, the syringes are used in combination with a suitable, automatic injection apparatus which mechanically controls the advance of the pistons as a function of the desired flow rate. The movement of these pistons is relatively powerful and precise, this fact being used to assure rupture of the sealing members.

For this purpose, one end of the piston 5 is in the shape of a point 7. Thus, in the use of the syringe, one places the piston 5 on an end of the rod 9, which may be connected to an automatic injection apparatus, and one places the syringe which includes the body 1 together with its associated sealing member 4 in its holding cradle (not shown).

The apparatus which acts upon the piston rod 9 pushes the piston 5 whose point 7 pierces the sealing member 4. The resulting pieces of the sealing member 4 are pushed between the interior wall of the hollow, cylindrical body 1 of the syringe and the piston 5. The sealing member 4 is sufficiently thin and the sealing flange 6 of the piston 5 is sufficiently elastic to make this passsage possible.

Ina variant of the syringe illustrated in FIGS. 1 and 2, shown in axial cross-section in FIG. 3, the syringe includes a hollow, cylindrical body 1 which is equipped with a piston 5 after being filled and prior to having a sealing member (membrane) 11 attached. However, the prolonged contact of the piston 5 and the injection fluid can be detrimental to good preservation of the fluid. For this reason, a sealing member (membrane) 10 is placed between the piston 5 and the fluid within the hollow, cylindrical body I. In order to facilitate the insertion of the sealing member 10 when the syringe is being filled, it has substantially the shape of a bell or the like, or of a cylinder having a closed cone at one end.

FIG. 3 is an illustration of a section through the syringe partially showing the hollow, cylindrical body 1, the piston 5, a flange 3, and the rod 9. The piston 5 has same shape as the embodiment of FIGS. 1 and 2, and includes a point 7. The sealing member 10 is shaped as a cylinder having a closed-cone configuration on one end, the other end being open. The sealing member 10 almost completely surrounds the piston 5 and is pressed against it. Its free, open end, which forms a second flange, is fused or otherwise fixed to the first flange 3, as in the embodiment shown in FIGS. 1 and 2. The sealing member 11, which is planar, is superimposed over the sealing member 10 at the rear portion of the piston 5 in order to hold it in place.

The use of the syringe illustrated in FIG. 3 is even simpler than the one shown in FIGS. I and 2, because it is sufficient to merely place it in its holding cradle (not shown). A piston rod 9, actuated by an automatic injection apparatus, ruptures the sealing member 11 and subsequently pushes the piston 5 whose point 7 pierces the sealing member 10, the remaining pieces of which are pushed against the internal wall of the hollow, cylindrical body 1 just as in the embodiment of FIGs. l and 2.

In yet another variant based on the structure of FIG. 3 when the syringe is placed into operation, the piston 5 ruptures the sealing member 10 near the line of its attachment to the flange 3 and not at its closed end. For this purpose, the thickness and/or the strength of the sealing member 10 is lower in the vicinity of the flange 3 than in the other parts of the same sealing member 10. This reduction of the thickness and/or the strength, which constitutes a rupture region for the sealing member 10, is obtained, for example, by the partial removal of portions of the material of the sealing member 10 during the operation of fusing or otherwise fixing the sealing member 10 on the flange 3. After rupture has occurred in the vicinity of its fusing line, the sealing member 10 is pushed along by the piston 5 during its entire travel within the hollow, cylindrical body I.

In still another variant, which is illustrated in FIG. 4, a sealing member (membrane) 12 replaces the sealing member 10 (FIG. 4) and is a part of a piston 5, i.e., the elastic material of the piston 5, which should not come in contact with the fluid, is covered,with a plastic foil which constitutes the sealing member 12, the foil adhering to the piston 5. The plastic foil constituting the sealing member 12 extends radially outward from the rear portion of the piston 5 and forms a second flange 13 so that the sealing can be affixed to the first flange 3. When the syringe is placed in operation, the flange 13 separates from that part of the sealing member 12 adhering to the piston 5 because of displacement of the piston 5 by a piston rod 9. The plastic foil constituting the sealing member 12 is sufficiently thin and flexible so that it can produce an acceptable fluid tightness between the piston 5 and hollow, cylindrical body I of the syringe during the entire travel of the piston 5. Furthermore, the piston 5 and the sealing member 12 stick together and the sealing member 12 is fused to the edge of the flange 3 of the syringe; consequently, it is no longer necessary to provide a second sealing member, such as sealing member 11 (FIG. 3) in order to hold the piston 5 within the body 1.

As shown in axial section in FIG. 5, the most preferred embodiment of the invention, includes a hollow, cylindrical body I of the syringe which terminates at its output end as a sleeve 2 including a fluid-tight tip 20 intended to be cut off or otherwise ruptured during use. At its entry end, the body I of the syringe is terminated by a first flange 3 by means of which the body I is held in position in an injection apparatus at one end face; the other, free, face having a plane, annular form lying perpendicular to the axis of the body 1, is equipped with a sealing member (membrane) which closes it in a fluid-tight manner; and also constitutes a piston 50 which is provided with a number of sealing, stiffener flanges 6 which contact the interior wall of the body 1.

In this preferred embodiment, the piston 50 of the syringe is itself made of a relatively flexible plastic material which is resistant to the injection fluid contained permanently in the syringe body 1 prior to its utilization. Such a choice of materials makes it possible to omit the sealing member 4, l0, and 12, (FIGS. 2 and 3, 4) and to manufacture a sealing assembly, comprising the piston 50 and a second sealing flange 51, out of one single piece of plastic, for example, polypropylene.

Prior to the use of the syringe,.the .piston 50 is held fixed in the interior of the syringe body 1, and thesec nd flange 51 is fused to thefree face of the first flange 3, in such a way as to insure the fluid-tightness and sterility of the fluid contained within the syringe body 1.

The thickness of the secondflange 51, at the points where it is joined to the piston 50, is reduced in thickness by a groove 52in order to create a rupture region between the piston 50 and the flange 51 which permits easy separation when the piston 50 is pushed into the body 1 of the syringe under the action of an operating rod 9.

in a preferred variant of this embodiment, the piston 50 is itself hollow and a tip 90 at the end of the operating rod 9 has the same shape as the interior of the piston 50.-ln effect, the piston 50 constitutes an assembly comprising a flexible piston and a sealing member where one part of the body of the piston 50 is formed in a shape complimentary to the tip 90, which is made of a rigid material.

Incidentally, the tip 90, at a distance of its end corresponding to that between the interior bottom of the piston 50 and its junction with the second flange 51, carries an enlargement 91 whose outer diameter is approximately equal to the outer diameter of the piston 50. The enlargement 91 terminates in an edge with a sharp angle 92 facing the syringe body and forming a kind of circular blade intended to cut the junction 52 between the second flange 51 and the major portion of the piston 50.

In the same embodiment, the piston 50 is hollow and flexible and essentially constitutes a sealing assembly and carries at least one or preferably the several sealing stiffener flanges 6 of classical annular form, such as are described previously and shown in FIG. 3, as well as an end reinfforcement 60 of considerable length and terminated at a sharp angle facing the outlet end of the syringe. When the tip 90 is completely pushed into the hollow piston 50, the end reinforcement 60 is strongly pressed against the internal wall of the syringe body 1 and insures excellent sealing between the piston 50 and the body 1.

Such syringes are really ready to use. They are especially adapted to use in automatic injection systems and apparatus, especially to those which, because of prolonged injection times, use a mechanism wherein several syringes are placed into operation successively and where an empty syringe must immediately be replaced by a full one.

It is to be appreciated that the foregoing description of preferred embodiments and variants thereof are set out by way of illustration, not of limitation. Numerous other embodiments and further variants are possible within the spirit and scope of the invention, the scope being defined by the appended claims.

What is claimed is:

1. A syringe which may be used for storage and preservation of injection fluid comprising, in combination:

a. a hollow, cylindrical body having an outlet end and an inlet end;

b. a rupturable member at said outlet end;

c. means defining a sealing surface at said inlet end;

d. a sealing member which is fixed to said sealing surface to seal said inlet end;

e. rod means; and

f. a piston connected to said rod means and movably positioned within said hollow cylindrical body for rupturing said sealing member and moving toward said outlet end; and wherein said rod means is separable from said piston; and further including means for holding said piston separately from said rod means, within said hollow, cylindrical body;

whereby injection fluid stored and. preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod means.

2. A syringe according to claim 1, wherein said sealing surface is a surface of a first flange facing axially away from said hollow, cylindrical body; said sealing member is in the form of a hollow member having a substantially conical closed first end, said sealing member surrounding a portion of said piston, being inserted between said piston and the interior wall of said body and having a second end in the form of a second flange located exteriorly of said body, said second flange being joined to said first flange.

3. A syringe according to claim 2, further including a second sealing member covering the rear of said pis ton, said second sealing member being joined to said first flange via said second flange so as to hold said pis ton within said body.

4. A syringe according to claim 2, wherein said sealing member is provided with a rupture region defined by a thickness reduction therein substantially adjacent said first flange.

5. A syringe which may be used for storage and preservation of injection fluid comprising, in combination:

a. a hollow, cylindrical body having an outlet end and an inlet end;

b. a rupturable member at said outlet end;

c. means defining a sealing surface at said inlet end;

(1. a sealing member which is fixed to said sealing surface to seal said inlet end; e. rod means; and f. a piston connected to said rod means and movably positioned with respect to said hollow cylindrical body for entering its interior, rupturing said sealing member and moving toward said outlet end;

wherein said sealing surface is a surface of a first flange facing axially away from said hollow, cylindrical body; and

wherein said sealing member is composed of a member which intimately, adhesively adheres to a portion of said piston, said portion being located within the .interior of said body, said sealing member having a free portion in form of a second flange, and said first flange being joined to said sec ond flange ina fluid-tight manner whereby injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod means.

6. A syringe which may be used for storage and preservation of injection fluid comprising, in combination:

a. a hollow, cylindrical body having an outlet end and an inlet end;

b. a rupturable member at said outlet end;

c. means defining a sealing surface at said inlet end;

d. a sealing member which is fixed to said sealing surface to seal said inlet end;

e. rod means; and

f. a piston connected to said rod means and movably positioned with respect to said hollow cylindrical body for entering its interior, rupturing said sealing member and moving toward said outlet end;

wherein said sealing surface is a surface of a first flange facing axially away from said hollow, cylindrical body;

wherein said sealing member and said piston are one and the same member, this member being of a material suitable for prolonged contact with the stored fluid within said body and being provided with a second flange which is joined to said first flange to provide a sealed fluid-tight closure for said body; and

wherein said second flange is provided, at its joint with that portion of said sealing member constituting said piston, with a region of reduced thickness constituting a rupture area whereby injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod means.

7. A syringe according to claim 6, wherein said rod means includes a tip portion having an enlargement having a diameter which is substantially equal to the outer diameter of that portion of said sealing member constituting said piston; and said enlargement, at its end facing said body is terminated by a sharply angled edge forming a circular blade which permits cutting between said second flange and that portion of said sealing member constituting said piston when said tip is pushed into the interior of said body. 

1. A syringe which may be used for storage and preservation of injection fluid comprising, in combination: a. a hollow, cylindrical body having an outlet end and an inlet end; b. a rupturable member at said outlet end; c. means defining a sealing surface at said inlet end; d. a sealing member which is fixed to said sealing surface to seal said inlet end; e. rod means; and f. a piston connected to said rod means and movably positioned within said hollow cylindrical body for rupturing said sealing member and moving toward said outlet end; and wherein said rod means is separable from said piston; and further including means for holding said piston separately from said rod means, within said hollow, cylindrical body; whereby injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod means.
 2. A syringe according to claim 1, wherein said sealing surface is a surface of a first flange facing axially away from said hollow, cylindrical body; said sealing member is in the form of a hollow member having a substantially conical closed first end, said sealing member surrounding a portion of said piston, being inserted between said piston and the interior wall of said body and having a second end in the form of a second flange located exteriorly of said body, said second flange being joined to said first flange.
 3. A syringe according to claim 2, further including a second sealing member covering the rear of said piston, said second sealing member being joined to said first flange via said second flange so as to hold said piston within said body.
 4. A syringe according to claim 2, wherein said sealing member is provided with a rupture region defined by a thickness reduction therein substantially adjacent said first flange.
 5. A syringe which may be used for storage and preservation of injection fluid comprising, in combination: a. a hollow, cylindrical body having an outlet end and an inlet end; b. a rupturable member at said outlet end; c. means defining a seAling surface at said inlet end; d. a sealing member which is fixed to said sealing surface to seal said inlet end; e. rod means; and f. a piston connected to said rod means and movably positioned with respect to said hollow cylindrical body for entering its interior, rupturing said sealing member and moving toward said outlet end; wherein said sealing surface is a surface of a first flange facing axially away from said hollow, cylindrical body; and wherein said sealing member is composed of a member which intimately, adhesively adheres to a portion of said piston, said portion being located within the interior of said body, said sealing member having a free portion in form of a second flange, and said first flange being joined to said second flange in a fluid-tight manner whereby injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod means.
 6. A syringe which may be used for storage and preservation of injection fluid comprising, in combination: a. a hollow, cylindrical body having an outlet end and an inlet end; b. a rupturable member at said outlet end; c. means defining a sealing surface at said inlet end; d. a sealing member which is fixed to said sealing surface to seal said inlet end; e. rod means; and f. a piston connected to said rod means and movably positioned with respect to said hollow cylindrical body for entering its interior, rupturing said sealing member and moving toward said outlet end; wherein said sealing surface is a surface of a first flange facing axially away from said hollow, cylindrical body; wherein said sealing member and said piston are one and the same member, this member being of a material suitable for prolonged contact with the stored fluid within said body and being provided with a second flange which is joined to said first flange to provide a sealed fluid-tight closure for said body; and wherein said second flange is provided, at its joint with that portion of said sealing member constituting said piston, with a region of reduced thickness constituting a rupture area whereby injection fluid stored and preserved within the hollow cylinder may be removed via the outlet end by the piston under the influence of the rod means.
 7. A syringe according to claim 6, wherein said rod means includes a tip portion having an enlargement having a diameter which is substantially equal to the outer diameter of that portion of said sealing member constituting said piston; and said enlargement, at its end facing said body is terminated by a sharply angled edge forming a circular blade which permits cutting between said second flange and that portion of said sealing member constituting said piston when said tip is pushed into the interior of said body. 